In the life sciences industry, the name of the game is often getting through preclinical studies and clinical trials. However, this feat is easier said than done. Many biotech, biopharma, pharma, and medical device companies need support to successfully conduct studies and trials.
Not every organization has the in-house capabilities, resources, and time to perform every trials-related task effectively and efficiently. When this is the case, businesses can rely on contract research organizations (CROs) for support with different stages of research and development.
This guide to CROs will help biotechnology, biopharmaceutical, and pharmaceutical companies select and collaborate with the right contract research organization, ensuring teams understand how CROs work, how to pick a good partner, and how to get full value out of these partnerships.
We’ll also review when it can make sense to lease lab equipment for in-house research and development alongside or in place of working with a CRO.
A CRO is an individual or team that provides research services on a contract basis to other organizations in the life sciences, including pharmaceutical companies, biotechs, biopharmas, medical device companies, and even research institutions, government agencies, and foundations.
The services CROs provide to help develop drugs, medical devices, biologics, and other healthcare-based products include clinical trial support, laboratory testing, regulatory support, and more. Which services an organization or team offers will depend on their areas of focus and expertise, as well as the organization’s size and capabilities.
Outsourcing certain tasks and duties can allow companies to skip maintaining staff for these functions while still moving a drug or device from conception and development to FDA approval.
Contract research organizations typically work on a contract basis, providing services for specific projects or for a set period of time. This business model is designed to reduce drug development costs for companies and simplify entry into drug markets, and usually present a cost-effective alternative to in-house research and development for a wide variety of research-based labs and organizations that do not have the resources or expertise needed to perform certain research tasks on their own.
Working with a CRO can be an effective and efficient option if you’re working towards getting a product to market, but unsure if you want to take on the financial costs of building out an entire research team in addition to acquiring the necessary equipment and facilities to perform the tasks related to your clinical trials in-house.
In addition to a variety of services, CROs range in company size. This means, depending on your needs, you can find a small, specialized group or a larger, full-service organization that can handle all aspects of conducting research and clinical trials.
CROS will also carry out all of its work according to Good Clinical Practices (GCPs) that ensure high-quality studies and full compliance throughout your preclinical studies and clinical trials.
CROs offer a wide range of services to support the pharmaceutical, biotechnology, and medical device industries, from project, data, and site management, to clinical study management, research compliance and education, medicine and disease coding, validation, product development and commercialization, quality control, biostatistics, and much more.
Depending on the organization, the list can be quite extensive. Review the exact services each can provide. Understanding your requirements first and then assessing the scope of their services and resources needed can help you find a contract research organization that’s right for you.
CROs can help design and manage clinical trials on behalf of other companies, from the initial planning stages to the analysis of the results. This may involve recruiting participants, collecting data, and monitoring the progress of the trial.
CROs can provide specialized laboratory testing services, such as toxicology testing, microbiology testing, and pharmacokinetic studies. These services help companies assess the safety and efficacy of their products.
Contract researchers can assist with the regulatory process and quality assurance, including preparing and submitting regulatory documents, such as registration and marketing applications, and providing guidance on compliance with regulatory requirements.
Contract researchers can also support drug discovery, product development, and conduct preclinical research on the safety and efficacy of new drugs, medical devices, and other products. This research typically involves animal testing and helps companies assess the potential risks and benefits of their products before they are tested in humans.
In addition to the services above, CROs can even help with other areas of research, including formulation development, process development, and analytical testing. These additional services can help laboratories improve the quality and effectiveness of their products.
There are numerous types of CROs actively supporting the life sciences today. Their differences can range from the level of specialization—which types of studies they specialize in—the types of services they offer, company location or size, and much more.
Some organizations offer end-to-end services, providing support with preclinical studies, phase I, II, and III clinical research, and even commercialization They also tend to have expertise in a wider variety of therapeutic areas. Others tend to specialize in a certain stage of research and development, or may have expertise in a specific therapeutic area or industry.
Below are a few examples of different ways you can categorize contract research organizations.
Clinical research organizations are CROs that specialize in conducting clinical trials on behalf of a client. They are usually responsible for designing the trial, recruiting participants, collecting data, and analyzing the results. In other words, they will handle clinical trial planning, data management, project management, site management, and trial monitoring.
These types of organizations can differ from other CROs who might provide services outside of clinical trials.
Laboratory testing CROs provide specialized laboratory testing services, and may not provide clinical trial support. Instead, they’ll likely focus on a specific type of testing, such as toxicology or microbiology, or offer a range of services related to testing your product for a variety of reasons.
Some CROs specialize in regulatory affairs. This means they can provide support with a variety of the regulatory processes pharmaceutical, biotechnology, and medical device companies have to undertake and comply with. They can typically help companies prepare and submit regulatory documents, such as registration and marketing applications, and provide guidance on compliance with regulatory requirements.
Preclinical research CROs can help conduct research on the safety and efficacy of new drugs, medical devices, and other products before they are tested in humans during clinical trials. This type of research can involve animal testing and relies on a range of techniques, such as toxicity testing and pharmacokinetic studies. Some CROs that specialize in preclinical research can also help you when it comes time to conduct clinical trials, and vice versa.
We’ve mentioned clinical research organizations are a type of contract research organization. However, this can make looking for an R&D partner somewhat confusing because both organizations share the same acronym.
Simply put, a contract research organization provides support to companies through a broad range of research support services, including study design, data management, and statistical analysis. These services can sometimes fall outside of clinical research and trials.
A clinical research organization, on the other hand, is a type of CRO that focuses specifically on the conduct of clinical trials, research studies that involve testing a new medical treatment, drug, or device in human subjects to determine its safety and effectiveness. CROs that specialize in clinical trials typically offer services such as site selection, study monitoring, and regulatory support—all to help conduct, manage, and monitor a clinical trial.
Contract research organizations are staffed by a range of professionals with expertise in the pharmaceutical, biotechnology, and medical device industries. This can include clinical research professionals, laboratory technicians, regulatory affairs managers, preclinical research associates and scientists, and much more.
Clinical research professionals, such as clinical research associates, clinical trial coordinators, and clinical trial managers, are responsible for planning, conducting, and managing a client’s clinical trials.
CROs that provide support with the regulatory process employ regulatory affairs professionals to help prepare and submit various regulatory documents. Regulatory affairs associates and managers can also provide guidance on compliance with different regulatory requirements the client will face.
Some CROS may employ laboratory professionals that are responsible for conducting tests and analyzing results. This can include laboratory technologists and technicians.
CROs that conduct preclinical research typically employ preclinical research professionals, such as preclinical research associates and preclinical research scientists. Like a clinical research coordinator or associate, these staff members are responsible for designing and conducting a client’s preclinical studies.
In addition to various research associates, technicians, managers, and coordinators, CROs may also employ other types of R&D professionals. This can include formulation scientists, process engineers, and analytical chemists, who provide specialized research and development services for clients.
There are several situations in which it can make sense to use a CRO to help with your business: lack of expertise or resources and cost or timeline inefficiencies are just two important reasons.
If you do not have the expertise or resources to conduct research and development in-house, CROs can provide the specialized expertise and resources needed to accelerate your research and fill in the gaps. This can be especially useful if you are a small company or if you are entering a new market or product area.
If you need to outsource research and development activities to save time and money, a contract researcher can—depending on the fees the organization charges—provide cost-effective R&D support, freeing up your team to focus on other tasks. Outsourcing can help you save time and money, and potentially help you get to market faster.
If you need support with the regulatory process, a contract research organization can provide guidance and support throughout the regulatory process, including preparing and submitting regulatory documents. With proper regulatory support, you’ll ensure you are in compliance with regulatory requirements and avoid costly delays or mistakes.
If you need to conduct clinical trials but lack the resources to do so, a CRO can design and manage the clinical trials on your behalf, from the initial planning stages to analysis of the results, making it easier to effectively and efficiently gather the data you need to support the safety and efficacy of your products.
Or, if you need to conduct preclinical research, a contract service provider can help conduct preclinical research on your products to assess their safety and efficacy before you go to clinical trials. Working with a CRO during your preclinical studies can help you more effectively identify any potential risks or benefits before moving on to test in humans, potentially saving you time and money in the long run.
When it comes time to choose a CRO to partner with, there will be several factors you’ll want to consider, including their level of organizational expertise and experience, the quality and compliance of their work, the cost and value for money, the organization’s ability to communicate and collaborate, and its timeliness and flexibility.
You will also need to find a contract research organization that has a proven track record supporting R&D in your specific therapeutic area or industry. Working with a contractor that doesn’t have experience doing so may inevitably lead to failure in preclinical or clinical research.
The CRO should have extensive expertise and experience in the specific area you are looking for support in, whether it’s conducting clinical trials or running laboratory tests. It can be helpful to look at each organization’s track record or the types of clients they have worked with in the past to assess their level of expertise.
The organization should demonstrate a strong commitment to quality and compliance, and should be able to provide evidence of their compliance with relevant regulations and standards. Like assessing their track record or client list, you can review a CRO’s quality management system and any certifications they have, such as ISO 9001 certification, to determine their levels of quality and compliance.
A contract researcher’s fees should be competitive and provide real value for money. In other words, the fees you pay should align with what you receive in return. To assess whether or not the organization’s worth their prices, you can sometimes ask for cost estimates for the services you are interested in and compare them to other CROs.
The CRO should be able to communicate effectively and collaborate with your team throughout the project. Poor communication and collaborative efforts can result in poor results and failed trials, so it’s important to establish whether or not the CRO is a strong communicator. If possible, you can ask for references from other clients and to speak with the CRO’s team directly to assess their communication and collaboration skills.
An organization should also be able to deliver the services you need in a timely manner and should be flexible enough to adapt to any changing needs or requirements. Ask about the CRO’s availability and their approach to managing project timelines to get a better idea of whether or not they can meet deadlines and remain flexible in the face of changes.
A CROs location can also be an important consideration when selecting a partner. If the drug or device you are developing together is expected to be approved in a variety of nations or locations, it will be beneficial—perhaps even necessary—to hire a CRO that has experience with the approval process in each location.
They may have facilities and staff positioned in the target location and will have knowledge about local regulations for clinical studies and approval.
Furthermore, because you’re outsourcing the work, you can easily lose oversight of the project. When a CRO’s team is conducting day-to-day tasks in another location, supervision can be more difficult, or even impossible. Comparing global CROs and local CROs and assessing how much supervision will be needed can help you understand whether or not location will be important in your selection.
Similar to working with a contract manufacturing organization (CMO), there are several advantages and disadvantages to working with a contract research organization.
The decision to use a CRO should be carefully considered, taking into account the potential drawbacks as well as the potential benefits.
Biotechnology, biopharmaceutical, and pharmaceutical companies often need support when it comes to preclinical, clinical trials, and other areas of research and development. There are a wide range of tasks, and not every company has systems and staff in place for every task or step.
However, rather than conduct the research in-house—spending the money to build out a team and acquire the necessary facilities and specialized equipment and securing all the necessary compliance certifications—laboratories can outsource the research to contract research organizations.
CROs come in quite handy when startups, small- and medium-sized businesses, and even large enterprises need to increase R&D efficiencies and decrease the time and cost to approval and market. Using a CRO, on the other hand, can be a good option if you don’t have the expertise or resources to conduct the research yourself, or if you need access to specialized equipment or facilities.
CROs typically have extensive experience and expertise in conducting research studies, and can provide a range of services, including study design, data management, and statistical analysis.
However, using a CRO can be more expensive than conducting the research in-house, and you may have less control over the research process. If you do conduct research in-house, you will undoubtedly need to keep a variety of high-quality research equipment on-hand to gather and manage your data.
Not having the proper lab equipment, as you well know, can greatly affect the results of your work, making it necessary to keep up with technology and equip your lab with the right instrumentation.
Leasing lab equipment with Excedr can be a cost-effective option for life sciences and biotech companies when you want to reduce the upfront costs on the equipment, protect it with comprehensive service coverage, and remain flexible when a new and better technology inevitably becomes available.
Rather than sink your money into a fixed asset and take a huge chunk out of your R&D budget, leverage our leasing program instead. Doing so is an excellent choice when or if you need a specific piece of equipment that you don’t have in-house, or if you need to expand your existing laboratory facilities.